FDA shares warning about Edwards Lifesciences heart valve tech after patient death
The U.S. Food and Drug Administration (FDA) is warning the public about safety concerns associated with certain delivery systems sold with the Sapien M3 transcatheter mitral valve replacement (TMVR) system from Edwards Lifesciences. The affected devices should not be used for patient care. Any delivery systems that are not part of this recall can still be used like normal.
The FDA announced this early alert due to issues with the Commander M delivery system that clinicians use to implant the Sapien M3 TMVR system during a minimally invasive procedure. Edwards Lifesciences has received multiple reports of balloons bursting during inflation.
“Potential injuries associated with balloon burst include embolism and inability to retrieve the device through the guide sheath, which may require additional intervention, including surgery,” according to the FDA’s advisory. “Because this patient population is deemed unsuitable for surgery, these interventions carry a high risk of serious adverse health consequences including death.”
One death and one serious injury have been linked to this issue so far.
What customers need to know
Four specific lots are included in this early alert:
- 67718561
- 67804014
- 67887043
- 67887044
Any delivery systems with these lot numbers should be removed and returned to Edwards Lifesciences.
The Sapien M3 system for transcatheter mitral valve replacement. Image courtesy of Edwards Lifesciences.
More details about the Sapien M3 TMVR system
The Sapien M3 TMVR system first secured FDA approval in January for the treatment of mitral regurgitation (MR). It was designed for patients with symptomatic moderate-to-severe or severe MR who may not be good candidates for mitral valve surgery or transcatheter edge-to-edge repair. The device is also indicated to treat high-risk patients who present with symptomatic mitral valve dysfunction linked to mitral annular calcification.
This early alert only includes the Commander M delivery system used to implant the valve. No issues have been identified with the actual Sapien M3 TMVR valve.
FDA is still investigating
This early alert is part of an FDA pilot program designed to help the agency communicate substantial safety risks while issues are still under investigation. The FDA has not yet determined the severity of this recall.
Cardiovascular Business will provide an update when more information is made available.
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Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.